There are a variety of abnormal conditions in the body which can be related to the wall(s) of hollow organs. Colonic polyps and tumors, endothelial vascular lesions, diverticuli, symptomatic internal hemorrhoids are some of the examples of these abnormal conditions. A treatment to such abnormal conditions from inside a hollow organ cavity or a lumen (so-called intra-luminal or endolumenal approach) may be beneficial to the patient since a surgical access trauma is reduced or eliminated.
One common condition that can be easily treated with the endoluminal approach is a symptomatic internal hemorrhoids condition. Internal hemorrhoids are conventionally treated using a variety of interventional and non-interventional endoluminal methods. An immediate proximity of internal hemorrhoids to the external orifice allows for a relatively easy access thereto. Several technologies for treating the internal hemorrhoids are currently available, but are fairly complex and/or frequently have less than acceptable clinical outcomes and/or high costs associated therewith.
Hemorrhoidal disease is a very common condition that can occur in more than half of the population by the age of 50. Currently, over 10 million people suffer symptoms from hemorrhoids in the United States, and one million new cases of symptomatic hemorrhoids are diagnosed annually. Approximately 10-20 percent of such cases may need a surgical removal of the hemorrhoid, which is associated with significant postoperative morbidity and high cost to the individuals and society.
The term “hemorrhoid” is generally used to refer to the disturbing perianal symptoms related to vascular complexes in the lower rectum and anus. This is usually associated with enlargement of this naturally occurring vascular tissue, which is responsible for its subsequent bleeding, prolapsing, thrombosis, itching, burning, etc. Repetitive straining due to constipation appears to be a leading factor in forming and progressing of hemorrhoids. The chances of having symptomatic hemorrhoids increase with age, pregnancy, obesity, sedimentary life, heavy lifting and genetic predisposition.
Various treatments can be tailored to the type and severity of the specific hemorrhoids. A pharmacological treatment, which is aimed at the regulation of defecation and symptomatic relief, may be less beneficial as likely having only a temporary and frequently incomplete effect. Current interventional, non-excisional, therapies are designed to obliterate blood supply to part of or to the entire hemorrhoid (e.g., rubber band ligation, infrared coagulation, injection sclerotherapy, ultrasound guided hemorrhoidal artery ligation, etc.). These treatments have modest, inconsistent clinical success with a frequent recurrence rate.
Rubber band ligation is one popular treatment method of hemorrhoids. In the rubber band ligation, some hemorrhoidal tissue is pulled into the ligator, and a rubber band is placed around the base of the pulled tissue. This causes a strangulation of the blood supply to a portion of the internal hemorrhoid and its overlying rectal mucosa. An ischemic necrosis and autoamputation of the hemorrhoid can generally follow in a few days, leaving an open rectal wound, which heals over several days. Severe and possibly debilitating postoperative pain is rare, but significant anal discomfort and tenesmus (a painfully urgent but ineffectual sensation or attempt to defecate) are frequent. Recurrences after the rubber band ligation are also frequent. In addition, since such treatment leaves the patient with an open wound in the anus for several days, the rubber band ligation may be rendered unsuitable for HIV-positive patients, and may require a demanding preparation for patients with bleeding disorders.
Sclerotherapy is another method for treatment of small internal hemorrhoids. A sclerosing agent is injected via a needle into and around the internal hemorrhoid. The rates of complications and recurrence of sclerotherapy can be high.
An ultrasound guided hemorrhoidal artery ligation involves manual suturing of the rectal tissues containing the hemorrhoial artery. The artery can be located by ultrasound radiation with an appropriate ultrasound arrangement. A resulting regression of the corresponding internal hemorrhoid would be expected. Since the suture-ligation can be performed above the internal hemorrhoid in the pain-insensitive zone, the procedure should be painless. However, such technique is demanding, and is highly dependent on the operator's experience and dexterity. Inexperience or lack of skill of the operator is responsible for both “missing” the hemorrhoidal artery and inadvertent rectal and vascular injuries. Hemorrhoidal artery injuries with resulting severe bleeding, rectal wall injury, etc. have been reported, and the recurrences are frequent.
The treatment of internal hemorrhoids with infrared coagulation can involve a blind heat coagulation of the branches of superior hemorrhoidal artery. Theoretically, when the branches of superior hemorrhoidal artery are successfully targeted, it can cause a subsequent regression of the corresponding internal hemorrhoid. However, since the exact location of the artery is not known, there is no guarantee that the infrared coagulation pulses reach the vessels and hence have any effect on hemorrhoids. Multiple treatments in a time span of several months are currently recommended by the distributor and treating doctors. The proper application of the infrared probe can be difficult with larger hemorrhoids due to obscurity of the interface between the probe and mucosa. Recurrences and ineffective treatment can be frequent.
Traditional surgical excision of hemorrhoids can be an effective but often a debilitating form of treatment. The hemorrhoidal tissue can be removed in longitudinal (parallel to main rectal axis) direction. Surgical excision of hemorrhoids may require the use of an anesthesia, and can cause a severe postoperative pain to the patient for several weeks along with a significant loss of work time therefor. Such technique is also dependent on the technical skill of the operator.
Another procedure, i.e., a Procedure for Prolapse and Hemorrhoids (PPH) can be used which involves circumferential excision of the rectal mucosa and submucosal layer proximal to the internal hemorrhoids using a circular stapler. As a result, a superior hemorrhoidal blood supply can be interrupted, while the hemorrhoidal tissue itself is left to ischemically regress. Since the excision is performed above the dentate line, a decreased postoperative pain and faster recovery (when compared to traditional hemorrhoidectomy) would likely occur. The internal hemorrhoids can consequently shrink within four to six weeks after such procedure. This PPH technique requires the implementation by highly skilled operators, as well as a significant learning curve, a general or regional anesthesia, and an expensive instrumental set-up. In addition, the use of PPH creates a substantial circumferential rectal trauma, which is likely excessive in the majority of cases when only 1 or 2 hemorrhoids are enlarged. A substantial circumferential injury of the anal canal and subsequent scarring can cause a rectal stricture (narrowing), which is debilitating and difficult to treat in patients. Serious complications during and after PPH have been previously reported.
Thus, there are several less invasive procedures than conventional surgery methods for the treatment of symptomatic internal hemorrhoids. However, such methods do not have the desired combination of simplicity, effectiveness and being substantially painless, minimally invasive, and inexpensive.
Accordingly, there is a need to provide a device and method which overcome at least some of the deficiencies with the previous devices and methods.